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bionectorTM

The Neutral Displacement, Umbilical catheters Split Septum, Needleless Connector

bionectorTM’s features and advantages

Why choose bionectorTM? When deciding which needleless connector to choose for your hospital, it is important to ensure that your choice meets the current ‘global standards’ for these devices. The global opinion leaders make a number of recommendations in terms of the essential features you should demand when choosing a needleless connector.(1,2,3,4)

• Neutral Fluid Displacement (3,7) This means that a specific post flushing clamping sequence is not essential as it is with positive and negative fluid displacement connectors.

• Low Priming Volume (3) Suitable for clinical applications where very low priming volumes and dead space are required. Bionector has a priming volume of just 0.03ml.

We have designed bionectorTM to meet these standards and furthermore, our clinical performance studies* provide the evidence to support our claim that bionectorTM meets these standards.

What do the global opinion leaders recommend? • A needleless connector that is supported by microbial ingress testing data. (1) • A split septum needleless connector is associated with a lower incidence of CRBSI compared to a mechanical valve needleless connector.(2,4) • A needleless connector with a smooth external septum surface with few, if any, gaps, that can be more thoroughly disinfected.(3) • A tight seal between the septum and the needleless connector housing to reduce or eliminate space for contamination to occur and biofilm to develop.(3) • A needleless connector with a direct, that is, straight fluid pathway that facilitates adequate flushing and reduces the internal surface for biofilm development.(3,4)

• A needleless connector with the most direct and least tortuous fluid pathway, with preferably no moving parts to reduce the potential risk of CRBSI.(3)

bionectorTM

• Direct Fluid Pathway (3,10)

• Cleanable Membrane (1,3,5)

Proven ‘flushable’ due to its straight fluid pathway. We can prove that macro and microscopic particles, for example blood, can be successfully flushed from the device.

Proven ‘cleanable’ using the latest disinfectants. Bionector has a smooth easy to swab membrane that fits very tightly into the device’s housing.

• A needleless connector with little or no dead space in the fluid pathway minimises the surfaces that infusates can contaminate and where biofilm can develop.(3) • A needleless connector that does not require a specific clamping sequence.(3) • A luer access mechanical valve needleless connector with little or no blood reflux. (3,4)

• MRI Compatible (8) Proven not to represent any risk to either patient or practitioner during an MRI of up to 3 Teslas.

• Effective Microbial Barrier (1,3,5,6) Supported by numerous microbiological studies which conclude that microbial ingress does not occur.

• Split SeptumTechnology (2,3) • CT-Rated compatibility(9) Approved for use with power injectors. . Maximum pressure resistance: 350 psi . Maximum flow rate: > 10 ml/s.

* Refer to the back page for more details.

Split septum needleless connectors have demonstrated a lower incidence of CRBSI than other designs of connector.

References 1. Food and Drug Administration Agency (FDA), ‘Guidance for Industry and FDA staff’: Pre-market notification submissions, Microbial Ingress Testing, section 8, page 9, July 11th 2008. 2. Centre for Disease Control, ‘Guidelines for the Prevention of Intravascular Catheter-Related Infections’, Needleless Intravascular Catheter Systems, page 19, No.6. 2011. 3. William R. Jarvis, MD, ‘Choosing the Best Design for Intravenous Needleless Connectors to Prevent Bloodstream Infections’. Infection Control Today, July 28th, 2010. 4. The Infusion Nurses Society, Infusion Nurses Standards of Practice; page S32, section 27, Practice Criteria A & B, 2011. 5. Efficacy of the Valve Systems of Needle-Free Closed Connectors, report 67-08, The Health Protection Agency UK, 21st May 2009. 6. An Evaluation of Bionector Microbial Integrity, report 65-07, The Health Protection Agency UK, 28th November 2007. 7. Bionector Fluid Displacement Test, report 200700807, Rev 01, Nelson Laboratories USA, 19th April 2007. 8. Bionector MRI Safety Testing, Shellock R & D Services Inc. USA, 4th March 2013. 9. CT Pressure Testing, Laboratoire Central d’Essai, Essai No. RE12176,Vygon SA France, 14th May 2012. 10. Blood Clearing Analysis, 5ml Flush GLP Report, report 201301574 Rev 01, Nelson Laboratories, USA, 15th April 2013. A summary of our clinical performance studies are detailed in the ‘bionectorTM Clinical Performance Studies brochure’. The full protocols and results are available in ‘The bionectorTM Electronic Handbook’. Please contact us directly or request copies directly from your local Sales Executive.

Technical specifications Latex-free Maximum duration of use Flow rate at gravity Priming volume MRI compatible Blood compatible Lipids resistant Alcohol resistant

Yes 7 days 105ml/min 0.03ml Yes Yes Yes Yes

Chlorhexidine resistant

Yes

•D o not place a cap, plug or obturator of any sort on bionectorTM other than a disinfecting cap. • Do not use a needle to access bionectorTM.

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• Remember to clean bionectorTM prior to access.

CRITICAL CARE For further information, please contact: questions@vygon.com The specifications given in this brochure are for information only and are not, under any circumstances, of a contractual nature.

Vygon – 5, rue Adeline • 95440 ECOUEN • FRANCE Reception: +33 (0)1.39.92.63.63 – Service clients France: +33 (0)1.39.92.63.81 Export customer service: +33 (0)1.39.92.64.15 Fax: +33 (0)1.39.92.64.44 • www.vygon.com